Devices & Diagnostics

Eko gets FDA clearance for digital stethoscope with ECG

The device can be used in a doctor’s office and could be prescribed to heart disease patients to support remote monitoring and reduce readmissions.

Eko's DUO device allows patients to record heart sounds and do an EKG test from home.

Eko’s DUO device allows patients to record heart sounds and do an EKG test from home.

Eko has secured 510(k) clearance for a second digital stethoscope that also has a 1-lead electrocardiograph (ECG) as well as heart sounds. In a phone interview, Eko CEO Connor Landgraf said Eko DUO heart monitor would be used to improve patient monitoring for heart conditions and simplify heart exams. It could also be prescribed to heart disease patients by physicians to support remote monitoring, not only to engage patients in their health but also to reduce readmissions.

“We put this technology into a friendly form factor,” Landgraf said. “We can use this device to understand systolic time intervals with a high amount of precision.”

The company previously received 510 (k) clearance for its Eko CORE digital stethoscope in 2015.

Landgraf noted that by combining ECG and heart sounds in one device, physicians could calculate time intervals and pattern recognition in a doctor’s office to detect heart abnormalities such as  arrhythmias, heart murmurs, and valvular heart diseases. It could also help physicians assess the impact of certain drugs on patients’ cardiac conditions.

As with its first CORE model, DUO is designed to provide a live-streaming service to support its use for telemedicine. Landgraf noted that the new functionality would be especially useful for remote monitoring and telemedicine. The information can also be integrated into electronic medical records.

Langraf said a wide variety of physicians have used CORE device and he expected similar interest in DUO. Although cardiologists make up many of its customers, they also include primary care physicians, telemedicine providers, as well as nurse and medical school students.

Given that more than 28 million people have heart disease in the U.S., according to data from the Centers for Disease Control and Prevention and that heart disease is the leading cause of death, adding a remote monitoring component seems like a logical step for the business. It also sets the business up to compete more directly with all the other businesses with mobile ECG.